[Ip-health] Boston Globe: FDA clears a generic biotech drug

[Amy Nunn]

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FDA clears a generic biotech drug


Case fails to clarify the approval process


By Diedtra Henderson, Globe Staff  |  June 1, 2006

WASHINGTON -- The Food and Drug Administration yesterday approved a generic
human growth hormone, a breakthrough that allows its maker to sell its first
copy of a biotechnology product in the United States.

The FDA, however, stopped short of resolving how it will approve more
complex generic biotechnology products.

Omnitrope, made by a unit of the Swiss drug maker Novartis
<http://studio.financialcontent.com/Engine?Account=bostonglobe&PageName=QUOT
E&Ticker=NVS>  AG , will treat children and adults with growth disorders .
The FDA determined it is so similar to branded products already on sale that
the agency could use its extensive knowledge of those drugs to approve
Omnitrope.

``This is a promising step in the right direction," said Senator Orrin G.
Hatch , Republican of Utah . He said the decision provides ``tangible hope"
that other generic biological drugs -- treatments produced in living cells
-- can be brought to market.

Omnitrope's development has been fraught with delays and marked by a legal
struggle. A federal judge in April told the FDA to rule quickly on
Novartis's application, which was filed in July 2003 .

``Hallelujah," said Les Funtleyder, a healthcare analyst at Miller Tabak +
Co. ``It's about time we got some clarity."

But in the complicated world of generic biologics, Omnitrope's application
was considered relatively simple.

The FDA already knows how human growth hormones work in people and what side
effects they cause. The agency, in a document posted on its website, said
that the more complex nature of other generic biological drugs makes it
difficult to confirm whether they are equivalent to their branded versions.

That's good news for local companies like Momenta Pharmaceuticals Inc., a
Cambridge company that uses sophisticated technology to ensure generic
versions of complex biotech drugs are equivalent to their brand-name
counterparts.

Yesterday's decision by the FDA ``potentially provides us with a competitive
advantage," said Alan Crane, Momenta's chief executive.

The effect is not so clear for companies aiming to sell generic versions of
recent blockbuster biotechnology drugs since the FDA said its approval of
Omnitrope does not create a clear pathway for those manufacturers to follow.
The multi billion-dollar unresolved question: How long will it take the FDA
to decide on an approval process? The absence of such guidelines is delaying
generic competition that would reduce prices on biotechnology drugs for
consumers and insurers.

``They're going to have to make a decision on this in the near future," said
Ken Kaitin , director of the Tufts Center for the Study of Drug Development
. ``There is going to be growing pressure from third-party payers as well as
the companies to make a decision."

The FDA also faces pressure from lobbyists representing pharmaceutical and
biotechnology companies that have argued the science used to create
biological drugs is too complex for the FDA to use shortcuts in approving
generic versions of their products.

``We note that FDA acknowledged it has not addressed all of the scientific
and legal issues," Caroline Loew, Pharmaceutical Research and Manufacturers
of America senior vice president , said in a statement. ``We look forward to
continuing to work with FDA through its consultative processes as it
addresses these issues."

Jim Greenwood , chief executive of the Biotechnology Industry Organization ,
said the association remains committed to protecting incentives for
innovation -- including patent rights -- and ensuring patient safety.

``It is important that FDA continue to require all the data -- including a
full complement of clinical studies -- necessary to show the quality,
safety, and effectiveness of biologics," Greenwood said in a statement.

Kathleen Jaeger, chief executive of the Generic Pharmaceutical Association ,
said yesterday's ruling sets ``historical precedent" that the FDA can apply
to approve other generic versions of hormones.

``The science clearly supports the approval of these particular products,"
she said.

The generic drug association is working with such policy makers as Hatch and
Representative Henry Waxman, Democrat of California -- authors of
legislation that already speeds the entry of cheaper generic drugs to market
-- to make clear the FDA's authority to decide such applications.

``Congress needs to step in now," Jaeger said.

European drug regulators have issued guidelines for generic copies of
biotechnology treatments and had already approved Omnitrope.



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